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Leventon S. A. U. recalls DOSI-FUSER 12591 5-500D1 -USA, 12591 5-600D1 -USA Provide parenteral drug infusions at a constant flow without impedi
Recalled September 4, 2019 · FDA recall Z-2360-2019 · Leventon S. A. U
Hazard
The product lacks 510(k) clearance, and therefore is misbranded and must be removed from the U.S. market. · FDA Class II
Units
1700
Sold at
US Distribution to states in: AZ, CA, MA, MI, PR, and FL.
Description
The product lacks 510(k) clearance, and therefore is misbranded and must be removed from the U.S. market.
Product
DOSI-FUSER 12591 5-500D1 -USA, 12591 5-600D1 -USA Provide parenteral drug infusions at a constant flow without impeding patient mobility
Manufacturer(s)
Leventon S. A. U.
Made in
Spain
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →